GENESIS II 71420804Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010209511), received between Jun 24, 2018 and Dec 2, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K951987); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED DURING THE ARTHROSCOPY PROCEDURE THAT THE GENESIS PE COULD NOT BE INSERTED. THE INCIDENT OCCURRED INSIDE THE PATIENT. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN AND IT WAS NECESSARY TO USE A BACKUP FROM SMITH & NEPHEW. ALTHOUGH THE SURGEON BLAMES THE DEVICE, HE WAS SATISFIED WITH THE SURGICAL OUTCOME. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934496 ↗
• InjuryJun 24, 2018Mechanical Problem; Mechanical Problem

  AFTER BONE CEMENT HARDENED, THE 1-2/11MM INSERT, WAS NOT ABLE TO EFFECTIVELY MOUNT ON THE BASEPLATE. BASEPLATE WAS THE 2 RIGHT. CLEANED THE SOFT TISSUE AROUND THE BASEPLATE SEVERAL TIMES, TRIED TO MOUNT SEVERAL TIMES, STILL FAILED. CONSIDERATION OF PATIENT SAFETY, CHANGED A 1-2/9MM INSERT TO COMPLETE THE SURGERY, THE JOINT WAS SLIGHTLY LOOSE. 12MINS DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7632767 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951987. One submission often covers many models, so check the product and lot details in each record.

• Z-1418-2022 · Jun 27, 2022 · Terminated
  (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
• Z-2774-2020 · Jul 16, 2020 · Open, Classified
  Tibial knee prosthesis
• Z-2883-2018 · Aug 1, 2017 · Terminated
  GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
• Z-0573-2016 · Nov 9, 2015 · Terminated
  Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 kn
• Z-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic